FDA Approves New Agents for Detecting and Treating Prostate Cancer

Prostate cancer reportedly affects one out of eight men in the United States.¹ Estimates suggest there will be over 268,000 newly diagnosed cases this year with the disease claiming the lives of 34,500 people.¹ However, the emergence of new modalities, recently approved by the Food and Drug Administration (FDA), may facilitate detection and treatment of prostate cancer.

For adults with metastatic castration-resistant prostate cancer (mCRPC), clinicians may employ the gallium-68 labeled imaging agent Locametz® (after radiolabeling) to identify prostate-specific membrane antigen (PSMA) positive lesions via positron emission tomography (PET) scans, according to the manufacturer Novartis.

A key phenotypic biomarker for assessing metastatic prostate cancer, PSMA is “highly expressed” in more than 80 percent of patients with the disease, noted Novartis. Not only does Locametz identify tumor lesions that express PSMA, the company said the imaging agent also identifies where the tumors have spread in the body.

These imaging findings can lead to targeted treatment with the newly FDA-approved Pluvicto™ (Novartis), which is a combination of ligand, a targeting compound, and a therapeutic radioisotope. Novartis said the agent is approved for the treatment of eligible patients with mCRPC. A recent study found the combination of Pluvicto and standard of care led to a 38 percent reduction in the risk of death as well as significant reduction in radiographic disease progression in comparison to the standard of care alone, according to Novartis.²

Oliver Sartor, MD, the medical director at Tulane Cancer Center, praised Pluvicto as a promising advance in targeted therapy for prostate cancer.

“The (FDA) approval of Pluvicto is an important clinical advancement for people with progressing mCRPC as it can significantly improve survival rates for those who have limited treatment options,” noted Dr. Sartor.

Novartis added that Locametz and Pluvicto will be available for clinicians in a few weeks.

References

1. American Cancer Society. Key statistics for prostate cancer. Available at: https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html . Updated January 12, 2022. Accessed March 28, 2022.

2. Pluvicto (prescribing information). Millburn, NJ: Advanced Accelerator Applications USA, Inc.2022.